UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063381 |
|---|---|
| Receipt number | R000072550 |
| Scientific Title | Associations Between Ensitrelvir and Hospitalization Outcomes Among Older Adults Aged 75 Years or Older With COVID-19: A Nationwide Claims Database Study |
| Date of disclosure of the study information | 2026/10/22 |
| Last modified on | 2026/10/22 23:10:00 |
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Basic information
Public title
A claims database study evaluating the association between ensitrelvir treatment and hospitalization among outpatients aged 75 years or older with COVID-19
Acronym
Ensitrelvir study in older adults with COVID-19
Scientific Title
Associations Between Ensitrelvir and Hospitalization Outcomes Among Older Adults Aged 75 Years or Older With COVID-19: A Nationwide Claims Database Study
Scientific Title:Acronym
Ensitrelvir and hospitalization outcomes in older adults with COVID-19
Region
| Japan |
Condition
Condition
Coronavirus disease 2019 (COVID-19)
Classification by specialty
| Infectious disease |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the association between ensitrelvir treatment and all-cause hospitalization within 7 days after COVID-19 diagnosis and treatment initiation among Japanese outpatients aged 75 years or older, using a claims database derived from the Late-Stage Elderly Healthcare System. Patients treated with ensitrelvir will be compared separately with patients receiving no antiviral treatment and those treated with molnupiravir.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Occurrence of all-cause hospitalization from Day 1 through Day 7, with the index date defined as Day 0. The index date is the first date during the indexing period on which an outpatient COVID-19 diagnosis and dispensing of an eligible treatment are recorded on the same date.
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 75 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients must meet all of the following criteria:
1.A COVID-19 diagnosis and dispensing of an eligible treatment are recorded on the same date during the indexing period from April 23, 2024, through February 28, 2025.
2.The COVID-19 diagnosis used to identify the index date is recorded in an outpatient claim.
3.An outpatient medical procedure or outpatient prescription or dispensing record is present on the index date.
4.The patient is aged 75 years or older on the index date.
5.Continuous medical and pharmacy data are available for at least 12 months before the index date.
6.The patient's observation end month is at least one month after the month containing the index date, or the patient dies during the month containing the index date.
7.The patient can be classified into one of the following cohorts according to treatment received on the index date: ensitrelvir, no antiviral treatment, or molnupiravir.
Key exclusion criteria
Patients meeting any of the following criteria will be excluded:
1.Missing age or sex.
2.A COVID-19 diagnosis or treatment with ensitrelvir, molnupiravir, nirmatrelvir/ritonavir, or remdesivir within 180 days before the index date.
3.Dispensing of more than one COVID-19 antiviral medication on the index date.
4.An inpatient or Diagnosis Procedure Combination claim with an admission date equal to the index date, or evidence of inpatient medical procedures on the index date.
5.Use of medications contraindicated with ensitrelvir or nirmatrelvir/ritonavir within 90 days before or on the index date.
Target sample size
100000
Research contact person
Name of lead principal investigator
| 1st name | Yoshitake |
| Middle name | |
| Last name | Kitanishi |
Organization
Shionogi & Co., Ltd.
Division name
Data Science Department
Zip code
530-0011
Address
GRAND GREEN OSAKA South Building Park Tower, 5-54 Ofuka-cho, Kita-ku, Osaka, 530-0011, Japan
TEL
+81-6-6202-2161
yoshitake.kitanishi@shionogi.co.jp
Public contact
Name of contact person
| 1st name | Satoki |
| Middle name | |
| Last name | Fujita |
Organization
Shionogi & Co., Ltd.
Division name
Data Science Department
Zip code
530-0011
Address
GRAND GREEN OSAKA South Building Park Tower, 5-54 Ofuka-cho, Kita-ku, Osaka, 530-0011, Japan
TEL
080-8520-8923
Homepage URL
satoki.fujita@shionogi.co.jp
Sponsor or person
Institute
Shionogi & Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Shionogi & Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
N/A : Not applicable due to database research
Address
N/A : Not applicable due to database research
Tel
0000000000
0000000000
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 10 | Month | 22 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2026 | Year | 10 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 10 | Month | 13 | Day |
Last follow-up date
| 2027 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is a non-interventional, retrospective, longitudinal cohort study using the JMDC claims database derived from the Japanese Late-Stage Elderly Healthcare System.
The study will include patients aged 75 years or older who are diagnosed with COVID-19 in an outpatient setting and receive an eligible treatment on the same date between April 23, 2024, and February 28, 2025. Patients will be classified into the ensitrelvir, no antiviral treatment, or molnupiravir cohort according to treatment received on the index date.
The primary analyses will separately compare ensitrelvir with no antiviral treatment and ensitrelvir with molnupiravir. Confounding will be addressed using propensity score-based inverse probability of treatment weighting. The risk of hospitalization within 7 days after the index date will be estimated, and associations will be summarized using risk ratios, risk differences, and corresponding 95% confidence intervals.
No ethics committee required as the study uses an anonymized database.
Management information
Registered date
| 2026 | Year | 10 | Month | 22 | Day |
Last modified on
| 2026 | Year | 10 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072550
